Article type
Year
Abstract
Background:
Poor recruitment is the most frequent reasons given for discontinuation of randomized controlled trials (RCTs). Ideally, such RCTs should disseminate both the lessons learned from recruitment failure, which might inform the planning of future trials, and the results in sufficient detail for inclusion in meta-analyses. To date, a comprehensive empirical collection of reasons for insufficient recruitment remains missing.
Objectives:
To examine the extent to which published RCTs that were discontinued due to poor recruitment reported on the recruitment process, lessons learned and trial results; and to gather reported reasons for poor recruitment.
Methods:
We identified eligible publications using (1) a previous collection of discontinued RCTs (published 2002 to 2013, Kasenda et al. JAMA 2014), and (2) a search of MEDLINE and EMBASE (2010 to 2013) using the recently introduced medical subject heading "Discontinued Trial" and synonyms for discontinuation and poor recruitment. We extracted RCT characteristics and the reporting of recruitment failure. We created a new classification system of reasons for poor recruitment.
Results:
We included 119 publications of RCTs discontinued due to poor recruitment. The median proportion of recruited participants from the planned sample size was 27% (interquartile range, 15% to 44%); 108 RCTs (91%) reported results in sufficient detail for inclusion in meta-analyses; 36 (30%) described the recruitment process, and 20 (17%) explicitly reported lessons learned. Overall, we identified 40 different reasons for insufficient recruitment; most frequent were “overestimated number of eligible participants” and “strong opinions among recruiters about study interventions”. Twenty-nine (73%) reasons for poor recruitment could have been addressed at the planning stage of the RCT.
Conclusions:
Most reports of RCTs discontinued for poor recruitment presented results in sufficient detail for inclusion in meta-analyses. Only a few stated lessons learned and details about participant recruitment. Most reasons for poor recruitment could have been addressed at the planning stage of the RCT.
Poor recruitment is the most frequent reasons given for discontinuation of randomized controlled trials (RCTs). Ideally, such RCTs should disseminate both the lessons learned from recruitment failure, which might inform the planning of future trials, and the results in sufficient detail for inclusion in meta-analyses. To date, a comprehensive empirical collection of reasons for insufficient recruitment remains missing.
Objectives:
To examine the extent to which published RCTs that were discontinued due to poor recruitment reported on the recruitment process, lessons learned and trial results; and to gather reported reasons for poor recruitment.
Methods:
We identified eligible publications using (1) a previous collection of discontinued RCTs (published 2002 to 2013, Kasenda et al. JAMA 2014), and (2) a search of MEDLINE and EMBASE (2010 to 2013) using the recently introduced medical subject heading "Discontinued Trial" and synonyms for discontinuation and poor recruitment. We extracted RCT characteristics and the reporting of recruitment failure. We created a new classification system of reasons for poor recruitment.
Results:
We included 119 publications of RCTs discontinued due to poor recruitment. The median proportion of recruited participants from the planned sample size was 27% (interquartile range, 15% to 44%); 108 RCTs (91%) reported results in sufficient detail for inclusion in meta-analyses; 36 (30%) described the recruitment process, and 20 (17%) explicitly reported lessons learned. Overall, we identified 40 different reasons for insufficient recruitment; most frequent were “overestimated number of eligible participants” and “strong opinions among recruiters about study interventions”. Twenty-nine (73%) reasons for poor recruitment could have been addressed at the planning stage of the RCT.
Conclusions:
Most reports of RCTs discontinued for poor recruitment presented results in sufficient detail for inclusion in meta-analyses. Only a few stated lessons learned and details about participant recruitment. Most reasons for poor recruitment could have been addressed at the planning stage of the RCT.